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国家食品药品监督管理局药品安全监管司关于举办世界卫生组织疫苗预认证申报程序培训班暨疫苗生产企业座谈会的通知


  附件2:
  世界卫生组织专家调查问卷表

  General information questionnaire
  Please take some time to answer the following questionnaire, which is aimed at getting general information on the profile of your company. Your responses will help WHO to understand where Chinese Vaccine manufacturers stand in relation to vaccine production, quality policy and general managerial and commercial approaches in place. The filled questionnaires will be collected by WHO staff during the meeting to be held on 1st March 2011

  I.          General understanding of the PQ procedure

  Q1: Is your company aware of the existence of the WHO vaccines' prequalification program
  □ No
  □ Yes

  Q2: Do you know how to submit an application of a vaccine produced by your company to WHO for prequalification evaluation?
  □ No
  □ Yes

  List the steps of which you are aware:

  Q3: What is the purpose of the WHO vaccines prequalification procedure?
  (more than one answer allowed)
  □ advise countries on the quality of vaccine
  □ a service to United Nations purchasing agencies
  □ advice to United Nations purchasing agencies on the quality, safety and efficacy of vaccines for purchase
  □ ensure compliance with WHO requirements and UN tender specifications
  □ monitor the quality of vaccines purchased through UN agencies
  □ other

  Q4: What are the principles of the prequalification procedure  (more than one answer allowed)
  □ ethical
  □ commercial
  □ reliance on NRAs
  □ Compliance with GMP
  □ Product safe and effective for target population
  □ Consistent quality
  □ Product meets WHO requirements and tender specifications
  □ Other

  Q5: What is the added value of the prequalification procedure (more than one answer allowed)
  □ replicates the work of the producing country NRA


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